The U.S. Food and Drug Administration (FDA) has issued warning letters to more companies that the agency claims are misbranding and misrepresenting their products as cures and treatments for Covid-19. These latest actions are part of a continued effort to crack down on unapproved, untested, or ineffective treatments for Covid-19 being sold to consumers.
Issued April 5 and 6, the letters target CofixRx LLC, a Michigan-based drug manufacturer, and wellerectile.com, an India-based web store. According to the FDA, the companies advertised products that constituted unapproved new drugs, misbranded products, and introduced these products into the U.S. stream of commerce in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
CofixRx LLC was accused of peddling a nasal spray called CofixRX Nasal Spray as a cure for Covid-19. In their warning letter, the FDA states, “your website offers your non-alcohol-based antiseptic product, CofixRX Nasal Spray, for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions in people.”
To support their claims, the FDA provided an excerpt from the CofixRX Nasal Spray label where it claims the spray “DESTROYS SARS CoV-2 and other COLD & FLU viruses in 15 seconds.” By the company’s own admissions on their site, this “patent-pending technology” is intended to provide “protection” for users from 45 seconds after application to 8 hours after application.
These claims have attracted the FDA’s ire due to the company’s claims of being able to “mitigate, prevent, treat, diagnose, or cure” Covid-19 without approval or authorization from the agency.
Wellerectile.com got into hot water with the FDA for offering products that were not only unauthorized to treat Covid-19, but other diseases as well. In their warning letter to the website, the FDA stated, “your website offers drug products for sale in the U.S. and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases such as malaria.”
The drug that the FDA was referring to was a hydroxychloroquine product called Hydroxychloroquine Tablets IP HCQS-200, which was manufactured by IPCA, a Mumbai-based pharmaceutical company. According to the site, “HCQS 200 mg (Hydroxychloroquine Sulfate) is used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. Its[sic] Also Proven Effective with Covid-19 Treatment.”
This statement required a more involved response than the simple cease-and-desist warning sent to CofixRx.
The FDA begins by noting, “While there are FDA-approved versions of hydroxychloroquine on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the ‘Hydroxychloroquine Tablets IP HCQS-200’ manufactured by IPCA and offered by www.wellerectile.com.”
The FDA-approved hydroxychloroquine is only approved for the treatment of “uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis.”
Furthermore, the FDA notes that “hydroxychloroquine has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.”
The FDA added that hydroxychloroquine is a restricted drug available by prescription only and is “intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for the intended uses.” Therefore, it is illegal to sell Hydroxychloroquine Tablets IP HCQS-200 online in the United States directly to consumers.
The FDA requested follow-up letters from both CofixRx LLC and wellerectile.com, noting that legal consequences would follow if their products were not corrected or removed. The FDA also noted that for international companies like Wellerectile.com, failure to comply would result in their products being refused entry into the country or detained.